ImpediMed is an ASX 300 company, and one of the fastest growing small companies on the ASX.

ImpediMed is the world leader in the development and distribution of medical devices employing Bioimpedance Spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status. ImpediMed’s primary product range consists of a number of medical devices that aid surgeons, oncologists, therapists and radiation oncologists in the clinical assessment of patients for the potential onset of secondary lymphedema. ImpediMed has the first medical device with an FDA clearance in the United States to aid health care professionals clinically assess secondary unilateral lymphedema of the arm and leg in women and the leg in men. As we expand we will require new employees to help develop and market our compelling product range.

Our current growth has resulted in the need for a Clinical Research Associate (CRA) Carlsbad CA location

ATTENTION CANDIDATES:Along with your resume, please provide a cover letter explaining your interest in this opportunity and why you are interested in working at ImpediMed.

Preparation of documentation as required for clinical trials ensuring all aspects of good clinical practice (GCP) are complied with.

This role requires close collaboration with study investigators, site coordinators, hospital staff, statisticians, and outside consultants.

Other duties as assigned

SUPERVISORY RESPONSIBILITIES

This position does not require supervising other employees.

TYPICAL KNOWLEDGE, SKILLS, & ABILITIES

A Bachelor’s Degree in a scientific discipline or equivalent experience.

Experience in co-ordination and monitoring of clinical trials.

Must understand, follow and comply with regulatory requirements as applicable to various processes. An understanding of FDA Quality System Regulations and ISO Standards (ISO 13485) is required.

Must possess a thorough understanding of work related standards and regulations, including but not limited to Standard Operating Procedures (SOPs) and Quality System Regulations (QSRs), both US and international.

Demonstrated knowledge Microsoft Office, CRM, SharePoint Server.

Strong organization, planning, and analytical skills with an attention to detail and accuracy.

WORK ENVIRONMENT & PHYSICAL REQUIREMENTS

Ability to travel as required to perform audits of clinical trial sites.

Ability to work collaboratively and within a strong team environment.

Ability to quickly establish credibility and relationships; ability to work with a variety of personalities and styles.

Experience as a self-starter and multi-tasker, self-motivated, with a capacity to perform in a fast paced environment, even in ambiguous situations.

Demonstrated ability to interact and collaborate with senior leadership and across functional departments.